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In this study, the weight of the contents in the cartridge was tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The produt accountability product accountability information was not provided for the nicotine replaement patches replacement patches.
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Row | STUDYID | DOMAIN | USUBJID | DASEQ | DAREFID | DATESTCD | DATEST | DACAT | DASCAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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1 | TEDP07 | DA | 10001 | | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.3 | g | 25 | 25 | g | 1 | 2004-06-06 | 2 | TEDP07 | DA | 10001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 23 | g | 23 | 23 | g | 1 | 2020-06-06 | 3 | TEDP07 | DA | 10001 | | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.1 | g | 25 | 25 | g | 1 | 2020-06-07 | 4 | TEDP07 | DA | 10001 | | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 10 | g | 14 | 14 | g | 2 | 2020-06-08 | 5 | TEDP07 | DA | 10001 | | CRT9955 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.2 | g | 25 | 25 | g | 2 | 2004-06-08 |
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EC was used to represent the collected exposure data since a double dummy -blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor represented each cartridge and patch used. The dose was represented as "1" to indicate one cartidge cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was reccorded on other days.
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Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e- nicotine liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The sponsor only represented the active product exposure for each subject in EX. Note, only repreesentive rows are included.
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXLOC | EXLAT | EXDIR | EPOCH | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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1 | TEDP07 | EX | 10001 | 1 | e nicotine liquid | 1.7 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-01T08:00 | 2020-06-01T:8:10 |
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2 | TEDP07 | EX | 10001 | 2 | e nicotine liquid | 15.1 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-01T12:10 | 2020-06-02 |
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3 | TEDP07 | EX | 10001 | 3 | e nicotine liquid | 13 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-02 | 2020-06-03 |
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4 | TEDP07 | EX | 10001 | 4 | e nicotine liquid | 12 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-03 | 2020-06-04 |
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5 | TEDP07 | EX | 10001 | 5 | e nicotine liquid | 9 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-04 | 2020-06-05 |
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6 | TEDP07 | EX | 10001 | 6 | e nicotine liquid | 7 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-10T08:30 | 2020-06-10T08:40 |
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7 | TEDP07 | EX | 10001 | 7 | e nicotine liquid | 5 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-10T12:40 | 2020-06-11 |
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8 | TEDP07 | EX | 20001 | 1 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | ARM | RIGHT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-01 | 2020-06-02 |
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9 | TEDP07 | EX | 20001 | 2 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | ARM | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-02 | 2020-06-03 |
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10 | TEDP07 | EX | 20001 | 3 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-03 | 2020-06-04 |
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11 | TEDP07 | EX | 20001 | 4 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | LEFT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-04 | 2020-06-05 |
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12 | TEDP07 | EX | 20001 | 5 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | RIGHT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-10 | 2020-06-11 |
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